Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer

This study has been completed.

Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

ClinicalTrials.gov Identifier:

NCT00017095

First Posted: January 27, 2003

Last Update Posted: October 24, 2013

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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.

PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.

First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen

Clinical and pathological responses [ Time Frame: after 3rd and 6d cycle of chemotherapy ]

Clinical response according to RECIST criteria without pathologic response [ Time Frame: after 3rd and 6d cycle of chemotherapy ]

Toxicity according to CTC v2.0 [ Time Frame: from randomization ]

Agreement between p53 assessment by IHC method and functional test in yeast by analyzing the correlation between p52 and tumor status after 3 and 6 cycles of chemotherapy [ Time Frame: after 3 and 6 cycles of chemotherapy ]

Tumor assessment using cDNA microarray technology [ Time Frame: end of treatment ]

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Ages Eligible for Study:

up to 70 Years (Child, Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer

Locally advanced or inflammatory disease

T4a-d, any N, M0 OR

Any T, N2 or N3, M0

Large operable T2 or T3 tumors

No bilateral breast cancer

Frozen tumor sample available

1 incisional biopsy OR

2 trucut biopsies from a 14G needle

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

70 and under

Sex:

Female

Menopausal status:

Not specified

Performance status:

WHO 0-1

Life expectancy:

Not specified

Hematopoietic:

Neutrophil count greater than 1,500/mm^3

Platelet count greater than 100,000/mm^3

Hepatic:

Bilirubin less than 1.2 mg/dL

SGOT less than 60 IU/L

Renal:

Creatinine less than 1.35 mg/dL

Cardiovascular:

LVEF normal by echocardiography or MUGA

Other:

No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

No serious uncontrolled medical condition

No uncontrolled psychiatric or addictive disorders

Not pregnant or nursing

Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017095